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COMPLETED NA

Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)

NCT04563039 · View on ClinicalTrials.gov ↗

Study Summary

A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones.

Conditions Studied

Interventions

  • DEVICE Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer
  • DEVICE Standard Ureteroscopic Laser Lithotripsy

Study Locations (20)

California

  • University of California — Irvine
  • University of California — San Diego
  • University of California — San Francisco

Florida

  • University of Florida — Gainesville
  • University of Miami Health — Miami

Kansas

  • University of Kansas Medical Center — Kansas City
  • Wichita Urology Group — Wichita

New York

  • Mount Sinai West — New York
  • SUNY Upstate Medical University — Syracuse

Pennsylvania

  • MidLantic Urology — Bala-Cynwyd
  • Penn State Milton S. Hershey Medical Center — Hershey

Alabama

  • University of Alabama — Birmingham

Arizona

  • Arizona Urology Specialists (Previously Arizona Institute of Urology, PLLC) — Tucson

Arkansas

  • Arkansas Urology Research Center — Little Rock

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2021-05-21
Est. Completion 2023-07-30
Phase NA

Sponsor

Avvio Medical

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04563039

The ClinicalTrials.gov registry entry for NCT04563039 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avvio Medical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Urinary Stones appearing as the primary indexed condition, and to 2 interventions — of which Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04563039 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04563039 about?

NCT04563039 is a clinical study titled "Acoustic Enhancer Research on Laser Lithotripsy (AEROLITH)". A pivotal study to evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscopic laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones.

What is the current status of trial NCT04563039?

This trial is currently completed. It is a NA study. The enrollment target is 196 participants. The study started on 2021-05-21. Estimated completion is 2023-07-30.

What conditions does trial NCT04563039 study?

This clinical trial studies the following conditions: Urinary Stones. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04563039?

The interventions under investigation include: Ureteroscopy Laser Lithotripsy (URS-LL) with Acoustic Enhancer (DEVICE), Standard Ureteroscopic Laser Lithotripsy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04563039?

This trial is sponsored by Avvio Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04563039 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial